Transcript Emergency Contraception for Medical Providers

Emergency Contraception
for Clinical Providers
in Washington State
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The New Yorker, July 23, 1999
“Don’t get me wrong. I think the morning after pill is great. It’s just that
right now my problem is lining up something for the night before.”
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Learning Objectives
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Understand the history and expanding role of
emergency contraception (EC) in pregnancy
prevention
Understand the differences between EC regimens
and their effectiveness
Identify mechanisms for raising awareness of EC
within the client population
Increase awareness of EC resources
Facilitate integration of EC into routine family
planning, reproductive health, and primary care
activities
Why Is Emergency Contraception
Needed?
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Around 10 million couples have sexual
intercourse every night in America
 Approximately 27,000 condoms break or slip
 Even perfect contraceptors can and do
experience contraceptive failure
Source: Trussell & Kowal, 1998.
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Current Proportion of
Unintended Pregnancies
United States: 49%
Washington State: 55%
Source: Henshaw, 1998; Schrager, 1997.
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Definition of Unintended Pregnancy
 Pregnancy that is unwanted or mistimed at conception
 Does not mean unwanted births/unloved children
 Does mean less opportunity to prepare:
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Prepregnancy risk identification
Management of preexisting conditions
Changes in diet and vitamins
Avoidance of alcohol, toxic exposure, and smoking
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The Institute of Medicine Recommends
That the Nation Adopt a New Social Norm
All pregnancies should be intended–
that is, they should be consciously and
clearly desired at the time of
conception.
Source: Institute of Medicine, 1995.
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Emergency contraception
prevents pregnancy
AFTER sex
Awareness of Emergency
Contraception is Limited
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Public uninformed about the method
 11%
of women know the basic facts about EC
 1% have used it
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These data are supported by PATH’s local
assessment, which found that most clients have
not heard about EC
Source: Kaiser Family Foundation, 1997
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Kaiser Family Foundation Survey:
Client Education
100%
Ob/Gyns
NPs/PAs
FPPs
58%
63%
40%
10%
11%
9%
0%
Rountinely Discuss EC
Always Discuss EC With
Patients Seeking Treatment
After Sex
Adapted from ARHP, 1999. Source: Kaiser Family Foundation, 1997.
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History of EC
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mid-1960s:
 early 1970s:
 1997:
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1998:
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1999:
High-dose estrogens in use
Combined OCs (Yuzpe regimen)
FDA announces that combined oral
contraceptives are safe and effective
for use as postcoital emergency
contraception
First dedicated product, Preven™,
approved by FDA
Progestin-only dedicated product,
Plan B™, approved by FDA
Adapted from ARHP, 1999. Source: Federal Register, 1997.
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What Is Emergency Contraception?
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Emergency Contraceptive Pills (ECPs)
 Often
referred to as “the morning-after pill”
 Birth
control pill hormones taken in high dose
within 3 days (72 hours) of unprotected sex
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IUD Insertion
 Within
 Can
5 days (120 hours) of unprotected sex
also be a long-term contraceptive method
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IUDs as Emergency Contraception
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99% effective in preventing pregnancies
 Can be retained for up to 10 years
 Screening should follow regular IUD screening
criteria plus ascertain unprotected intercourse
within 5 days of seeking treatment
Source: Trussell & Ellertson, 1995.
Two Types of ECPs
Progestin-only
 Reduces the risk of
pregnancy by 89%
 Side effects
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Estrogen and Progestin
 Reduces the risk of
pregnancy by 75%
 Side effects
Nausea (23%)
Vomiting (6%)
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Nausea (50%)
Vomiting (20%)
Both Methods:
First dose within 72 hours after intercourse
Second dose 12 hours later
Source: Task Force on Postovulatory Methods of Fertility
Regulation, 1998.
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Dedicated Progestin-Only Product
Plan B™
 Women’s Capital
Corporation
 FDA approved July 1999
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Effectiveness: Single-Use Progestin Only
100 women have unprotected sex in
the 2nd or 3rd week of their cycle
8 will become pregnant without
emergency contraception
1 will become pregnant using progestin-only ECPs
(89% reduction)
Adapted from ARHP, 1999. Source: Task Force on Postovulatory Methods of Fertility Regulation, 1998.
Dedicated Estrogen and Progestin
(Combined) Product
Preven™
 Gynétics
 FDA approved
March 1998
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Effectiveness:
Single-Use Combination Pill
100 women have unprotected sex in
the 2nd or 3rd week of their cycle
8 will become pregnant without
emergency contraception
2 will become pregnant using combined ECPs
(75% reduction)
Adapted from ARHP, 1999. Source: Trussell, Rodriguez, and Ellertson, 1998.
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Regular Oral Contraceptives Used for
Emergency Contraception
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In addition to dedicated ECP products, regular
birth control pills can be prescribed in special
doses for emergency contraception
(See table in your packet)
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Treatment Is More Effective the
Sooner It Begins
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<24 hours
25-48 hours
49-72 hours
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Pregnancy rate
(percent)
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Progestin-only
Progestin and Estrogen
Time from coitus to treatment
Source: Lancet, 1998
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ECP Mechanism of Action
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Clinical studies have shown that ECPs can inhibit or
delay ovulation
 Evidence regarding endometrial alterations equivocal
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clear that changes observed would inhibit implantation
Biologic plausibility regarding inhibition of fertilization
 Thickening
of cervical mucous
 Alterations in tubal transport of sperm or egg
Source: Swahn et al., 1996; Ling et al., 1979; Rowlands et al., 1986;
Ling et al., 1983; Kubba et al., 1986; Taskin et al., 1994.
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ECP Mechanism of Action
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Timing impacts how ECPs work:
 Cycle
day on which intercourse occurred
 Cycle day on which treatment is used
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Statistical evidence suggests there must be an
additional mechanism beyond delaying or
preventing ovulation
Source: Von Hertzen & Van Look, 1996; Trussel & Raymond,1999.
Medical Definition of Pregnancy
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NIH, FDA, and ACOG all define pregnancy as
beginning with implantation
 Takes about 6 days for a fertilized egg to begin
to implant
 Intervention within 72 hours cannot result in
abortion
 ECPs are not effective if a woman is already
pregnant
Source: Code of Federal Regulations, 1998; Hughes, 1972.
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Providing EC Information
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For some women, clearly
understanding the mechanism of
action will be critical to making an
informed choice about ECP use.
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Key Points on Mechanism of Action
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ECPs work through various mechanisms
 ECPs will not interrupt or harm an
established pregnancy
 ECPs are not the same as mifepristone
(RU486), which is used after pregnancy is
already established
ECP Safety:
Women’s Health
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According to the World Health Organization,
there are no absolute contraindications for ECPs.
 ECPs are believed to have no clinically significant
impact on conditions such as cardiovascular
disease, angina, acute focal migraine, or severe
liver disease.
 However, ECPs do not protect against STDs.
Source: WHO, 1996.
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ECP Safety:
Health of Fetus
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ECPs do not interfere with an established
pregnancy.
 No evidence that ECP hormones have an
adverse effect on fetal development.
Source: FDA, 1997.
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What are the key messages to
communicate to your clients?
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Key Messages for Clients:
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72-hour time frame for ECPs (but
sooner is better)
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Safe and effective
Mechanism of action (informed choice)
Do not cause abortion
Side effects: nausea and vomiting
Not as effective as other contraceptives
for regular use
Do not protect against STDs
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What other issues might be of
importance to clients?
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Key Topics of Importance to Clients
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No future impact on childbearing
No threat to potential pregnancy
Not abortion
Religion (individual’s religious background not
always predictive of EC interest)
Expense of ECPs (covered by Medicaid)
Confidentiality
 Adolescents
 Diverse communities
 Interpreters
Physician/Clinic Referral
or Follow-up
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No menses within 3 weeks after treatment
• 98% of women have menses within 21 days
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If client has concerns or problems
 For initiation of routine birth control method
 For information or screening for STDs
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Initiating Regular Contraceptive Use
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Condom
Diaphragm
Oral contraceptives
Injectable
or implant
IUD
immediately
immediately
immediately or after next
menses*
within 7 days after
next menses*
after next menses (for
long-term use)*
(*use back-up method until menses)
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Advance Distribution or
Advance-of-Need Prescribing of ECPs
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ECPs are more effective when taken sooner
Advance prescription reduces access barrier
Women are not more likely to use ECPs
repeatedly
Advance prescription does not decrease the use
of other birth control methods
Source: Glasier and Baird, 1998.
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Expanded Access Through Pharmacies
in Washington State
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Collaborative drug therapy agreement between
pharmacist and independent prescriber
Trained pharmacists participating in a collaborative
agreement can provide ECPs directly to women
who request them
Currently over 145 pharmacies participating
In the first 16 months of project pharmacists wrote
and filled almost 12,000 prescriptions for ECPs
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Medicaid Coverage of ECPs
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Medicaid covers ECP prescriptions
 Covers
Preven™ and Plan B™
 Covers regular birth control pills prescribed in
special doses for emergency contraception
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Medicaid covers pharmacist counseling time
 For
women who receive ECPs directly from
pharmacist, the pharmacist’s counseling time and
the ECP prescription are covered.
Cost of ECPs
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For prescriptions written by medical providers
(MDs, ARNPs, PAs):
 If
covered by insurance:
 If no insurance coverage:
• Plan B™:
• Preven™:
$5-10 co-pay
$18-35
$20-35
– Note: client also must pay for office visit to get prescription
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For prescription and consultation at pharmacy:
 Pills
and counseling:
$35-45
 As dedicated products become more widely used, cost
may rise slightly:
$40-45
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Tools Included in Provider Packet
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Q & A for medical providers
Key messages to convey to clients
Telephone screening protocol
EC referral card
Emergency Contraception: Client Materials for
Diverse Audiences booklet
List of pharmacies that provide ECPs in
Washington State
EC reference list
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EC Materials for Diverse Audiences
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Provides EC information in
13 languages:
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Amharic
Arabic
Cambodian
Chinese
English
Haitian-Creole
Korean
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Laotian
Portuguese
Russian
Somali
Spanish
Vietnamese
Clinics and Pharmacies that Provide
ECPs in Your Area
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EC Hotline
 1-888-NOT-2-LATE
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(1-888-668-2528)
EC website
 http://not-2-late.com
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Planned Parenthood website
 http://plannedparenthood.org
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Washington State Family Planning Hotline
 1-800-770-4334
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How will you emphasize ECPs
in your practice?
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Tell Your Clients About ECPs by:
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Routinely advising about ECPs
 Making ECP materials available in clinic
settings
 Encouraging advance-of-need prescribing
 Signing up to be listed as an EC provider on
the national hotline by calling
1-888-NOT-2-LATE (1-888-668-2528)
JWVP15045 (8/24/00)